On September 8, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that it intends to offer and sell, subject to market conditions, 10,000,000 shares of its common stock in an underwritten public offering (Press release, Athenex, SEP 8, 2020, View Source [SID1234573873]). In addition, Athenex expects to grant the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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SVB Leerink, RBC Capital Markets and Evercore ISI are acting as joint book-running managers and Oppenheimer & Co. is acting as lead manager for the offering.

The securities described above are being offered by Athenex pursuant to a shelf registration statement on Form S-3 (File No. 333-227492) that was filed with the Securities and Exchange Commission (the "SEC") on September 24, 2018 and became effective upon filing. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there by any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On September 8, 2020 Manifold Bio, a spinout from George Church’s lab at Harvard Medical School focused on dramatically increasing the throughput of protein therapeutics testing in vivo, announced the close of a $5.4 million Series Seed investment round (Press release, Manifold Bio, SEP 8, 2020, View Source [SID1234572307]). Playground Global led the round and was joined by pre-seed lead Fifty Years and early investors GETTYLAB and Allston Venture Fund. The investment will enable the company to expand the team and accelerate the development of a proprietary protein quantitation platform.

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Manifold Bio was founded by CEO Gleb Kuznetsov, Ph.D., and CSO Pierce Ogden, Ph.D., along with George Church, Ph.D., Professor of Genetics at Harvard Medical School and the Wyss Institute for Biologically Inspired Engineering. They are joined by co-founder and Head of Business Development Shane Lofgren who previously helped build companies that emerged from Stanford and MD Anderson.

"The most valuable data on a candidate drug comes from testing it in a living system," says co-founder and CEO Gleb Kuznetsov. "Despite the advent of high-throughput technologies early in the discovery pipeline, drug development teams eventually run into the bottleneck of testing only one molecule at a time in the most relevant biological assays and animals. At Manifold Bio, we’re focused on building a platform that removes this barrier and allows us and our partners to pursue cures for devastating diseases much more rapidly."

"We’ve seen exponential advances that allow us to synthesize millions of strands of DNA and sequence billions of DNA bases, but the number of drugs that can be tested in relevant animal models remains in the single digits," said co-founder George Church, who introduced Manifold Bio in a keynote last week at PEGS, the premier industry protein engineering conference. "With the technology and talented interdisciplinary team we’re building at Manifold Bio, we’ll be able to bring the massively parallel economics of multiplexing to bear on engineering protein therapeutics."

Manifold Bio’s platform will allow multiplexed (pooled) tracking and quantification of thousands of unique protein designs, including monoclonal antibodies and other protein therapeutic scaffolds, across a range of complex testing environments.

"By turning protein engineering into a DNA synthesis and sequencing problem, we’re able to learn biological design principles directly from rich data generated by our novel in vivo assays," co-founder and CSO Pierce Ogden said. Last year, Ogden published a ground-breaking paper in Science demonstrating in vivo screening of more than 200,000 gene therapy virus designs. "Now, we’re building the platform technology for the larger space of protein therapeutics. The key is making it possible to test and quantify mixtures of designs directly where it matters–in vivo disease models. These advances will pave the way toward our goal of transforming drug discovery into measurement-driven drug design."

"Too many of the drug discovery startups we see are focused primarily on computation and improving the beginning of the drug development funnel, only to revert to traditional and painfully inefficient artisanal methods as therapies approach the clinic," said Jory Bell, Partner at Playground Global. "Manifold Bio has developed an entirely new approach to engineering which profoundly impacts all phases of development."

"By enabling high throughput in vivo screening of protein therapeutics, Manifold Bio can discover new biologics at scale," said Seth Bannon, Founding Partner at Fifty Years. "Their approach allows generating valuable data faster and at a lower financial and ethical cost, leading to cures that have evaded traditional methods."

Playground Global’s Jory Bell will join Manifold Bio’s board of directors.

On September 8, 2020 Silence Therapeutics plc, AIM:SLN and NASDAQ: SLN ("Silence" or "the Company") a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported that provides a research and development update (Press release, Silence Therapeutics, SEP 8, 2020, View Source [SID1234568596]).

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Pipeline progress

SLN360

·Silence’s wholly owned lead product candidate SLN360 for the treatment of cardiovascular disease associated with high Lipoprotein(a), or Lp(a), levels, has received approval from the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to start dose escalation studies in healthy volunteers and secondary prevention patients with elevated Lp(a). SLN360 is designed to address increased cardiovascular risk associated with raised levels of Lp(a), which is considered to affect up to 10% of the world’s population. Whilst we are aiming to start dosing healthy volunteers in the Phase 1 trial by the end of the year, the Covid-19 pandemic may put this timing at risk.

SLN124

Silence has initiated dosing in its randomised, double-blind, placebo-controlled Phase 1 single-ascending dose study of SLN124, the Company’s wholly owned product candidate for beta-thalassaemia and myelodysplastic syndrome (MDS), in up to 24 healthy volunteers. This marks the first dose of a Silence siRNA therapeutic delivered to humans using the Company’s proprietary GalNAc-siRNA platform. GalNAc is a naturally occurring sugar that binds specifically to a receptor which is highly expressed on liver cells, or hepatocytes. Coupling GalNAc sugars to stabilized siRNA molecules allows them to specifically target liver cells and carry out their function.
The FDA recently granted SLN124 orphan drug designation (ODD) for the treatment of adult beta-thalassemia. The FDA previously granted SLN124 ODD for MDS and rare paediatric designation for beta-thalassaemia. SLN124 also has ODD for the treatment of beta-thalassaemia from the European Medical Agency.
Complement Collaboration

·Silence is pleased to announce work commenced on the second target being explored under its complement pathway RNAi collaboration with Mallinckrodt, which triggered a $2.0 million research milestone payment to the Company. Silence would be entitled to receive an additional $2.0 million research milestone payment if work commences on a third target in the collaboration.

Iain Ross, Executive Chairman of Silence Therapeutics, said: "In what has been a busy and successful year for Silence, we have continued to make significant progress with our R&D pipeline. We are delighted to announce today that we have received FDA approval of the IND application for our wholly owned lead product candidate, SLN360, which is designed to address a significant unmet medical need in cardiovascular disease for people born with high Lp(a) levels. We have also made strong progress with our wholly owned product candidate, SLN124, having now dosed the first healthy volunteer. This marks the first dose of a Silence GalNAc-siRNA given to humans and is the culmination of several years’ work in developing this platform. This is truly an exciting time for Silence and we look forward to providing further updates as we move ahead."

On September 8, 2020 Genenta Science, a clinical-stage biotechnology company pioneering the development of a hematopoietic stem cell gene therapy for cancer (Temferon), reported that they will present data from the TEM-GBM study at the Advanced Therapies Congress & Expo 2020 (Press release, Genenta Science, SEP 8, 2020, View Source [SID1234568502]).

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Dr. Carlo Russo, Chief Medical Officer and Head of Development at Genenta, will provide an overview of Temferon, the company’s pipeline and the latest preliminary clinical data in patients affected with glioblastoma multiforme, on September 9, at 6.50pm CET.

On September 8, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based circulating cell-free tumor DNA (ctDNA) analysis for oncology, reported the publication of a clinical study investigating the utility of cfDNA-based markers using the highly sensitive OncoBEAM RAS assay, an enhanced digital PCR test optimized for high sensitivity blood-based mutation detection, as a prognostic tool in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Sysmex Inostics, SEP 8, 2020, View Source [SID1234568256]).

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Pancreatic cancer is the fourth leading cause of cancer related death worldwide. Moreover, PDAC accounts for 90% of all pancreatic cancers with an overall 5-year survival of less than 8%, the lowest survival rate of all cancers. Patients diagnosed with PDAC suffer from a poor prognosis which is attributed to diagnosis at an advanced stage, due to late onset of symptoms and lack of reliable biomarkers for early detection. Moreover, most patients with late stage disease exhibit resistance to available therapy modalities.

The primary initiating genetic event for PDAC is a KRAS mutation, occurring in 94% of pancreatic ductal tumors. KRAS mutational status is typically analyzed in tumor tissue but obtaining biopsy specimens from pancreatic lesions – especially during chemotherapy treatment – may be difficult and requires invasive procedures. Tumor tissue for biomarker testing is only available at diagnosis and is not feasible to access during treatment. CfDNA-based liquid biopsy analysis of KRAS mutations using OncoBEAM technology represents a minimally-invasive tool to measure levels of circulating KRAS mutations to assist in the prognosis determination and management of PDAC patients.

The study published by investigators at the University of Córdoba, Spain indicates that the dynamics of circulating RAS mutations may better correlate with patient outcomes and survival compared with CA19-9 protein blood-based marker testing. CA19-9 is usually found in higher concentrations in pancreatic cancer, however, it is not a tumor specific biomarker and can be elevated for reasons unrelated to cancer. In this comparative analysis, a significant correlation was found between the increase in RAS mutation levels detected in plasma by the OncoBEAM RAS test (r = 0.65, p = 0.02), but not in CA19-9 (r = 0.09, p = 0.78) and survival time. Overall, greater increases in levels circulating KRAS mutation during patient monitoring predicted shorter survival time, with researchers noting that KRAS mutant cfDNA shows great promise as real-time biomarker of tumor response.

Lead author Dr. Toledano-Fonseca of Maimónides Biomedical Research Institute of Córdoba (IMIBIC), said, "Remarkably, sensitive plasma KRAS mutation testing using OncoBEAM alongside of CA19-9 and fragmentation analysis greatly helped prognosis stratification of metastatic PDAC patients. Our results support KRAS MAF as a valuable complementary tool for monitoring the response to chemotherapy treatment in metastatic PDAC patients."

The publication, titled "Circulating Cell-Free DNA-Based Liquid Biopsy Markers for the Non-Invasive Prognosis and Monitoring of Metastatic Pancreatic Cancer" was published in Cancers, July 1, 2020, by Marta Toledano-Fonseca et al.: View Source